QA Manager
Core
Own the Quality Management System (QMS) for a clinical AI software product (SaMD) across Australia and the UK, leading to ISO 13485 certification.
Role type
Senior Quality Management Representative / Quality Manager
Builds
A compliant Quality Management System (QMS) and post-market surveillance framework for a Software as a Medical Device (SaMD)
Domain
Healthcare technology / Medical Devices / Regulatory Compliance
Deliverable
production ML models
Required skills
ISO 13485, ISO 14971, eQMS implementation, audit leadership, risk management, design controls, post-market surveillance
Preferred skills
IEC 62304, medical device cybersecurity, multi-jurisdictional QMS experience, startup environment
Technologies
eQMS platforms, ISO 13485, ISO 14971, IEC 62304
Responsibilities
Lead path to ISO 13485 certification, own the Quality Manual, ensure eQMS governance, design post-market surveillance, lead Management Review, run internal self-audits, embed design controls and risk management
Seniority
Senior, hands-on IC with management responsibilities